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Effects of Growth Hormone Releasing Hormone in HIV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01263717
First received: December 16, 2010
Last updated: October 10, 2014
Last verified: October 2014
History of Changes
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Lipodystrophy
Interventions: Drug: tesamorelin
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tesamorelin Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo (Inactive Injection) Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase

Participant Flow:   Overall Study
    Tesamorelin     Placebo (Inactive Injection)  
STARTED     28     26  
Baseline Visit     28     22  
COMPLETED     23     20  
NOT COMPLETED     5     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tesamorelin Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
Placebo (Inactive Injection) Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
Total Total of all reporting groups

Baseline Measures
    Tesamorelin     Placebo (Inactive Injection)     Total  
Number of Participants  
[units: participants]
 		  28     22     50  
Age  
[units: years]
Median (Inter-Quartile Range) 		  49  
  (46 to 54)   		  53  
  (49 to 58)   		  51.5  
  (46 to 56.25)  
Gender  
[units: participants]
 		     
Female     4     4     8  
Male     24     18     42  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     20     14     34  
Black     6     3     9  
Hispanic     1     3     4  
Other     1     2     3  
Region of Enrollment  
[units: participants]
 		     
United States     28     22     50  



  Outcome Measures
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1.  Primary:   Liver Fat   [ Time Frame: 6 months ]
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2.  Primary:   Visceral Adipose Tissue   [ Time Frame: 6 months ]
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3.  Secondary:   Intramyocellular Lipid   [ Time Frame: 6 months ]
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4.  Secondary:   Endogenous Growth Hormone Secretion   [ Time Frame: 6 months ]
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5.  Secondary:   Insulin Sensitivity   [ Time Frame: 6 months ]
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6.  Secondary:   HbA1c   [ Time Frame: 6 months ]
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7.  Secondary:   Insulin Like Growth Factor 1 (IGF-I)   [ Time Frame: 6 months ]
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8.  Secondary:   Lipid Panel   [ Time Frame: 6 months ]
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9.  Secondary:   Carotid Intimal Medial Thickness (cIMT)   [ Time Frame: 6 months ]
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10.  Secondary:   Glucose Tolerance   [ Time Frame: 6 months ]
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11.  Secondary:   Adiponectin   [ Time Frame: 6 months ]
  Show Outcome Measure 11

12.  Secondary:   Hemostatic Markers   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven K. Grinspoon, MD
Organization: Massachusetts General Hospital
phone: 617-724-9109
e-mail: sgrinspoon@partners.org


Publications of Results:


Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263717     History of Changes
Other Study ID Numbers: 2007p-000638
Study First Received: December 16, 2010
Results First Received: September 8, 2014
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration